Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLARITHROMYCIN
STADPHARM SDN. BHD.
CLARITHROMYCIN
28 Tablet Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CLARITHROMYCIN STELLA 500MG FILM- COATED TABLET Clarithromycin 500mg 1 WHAT IS IN THIS LEAFLET 1. What Clarithromycin STELLA 500mg is used for 2. How Clarithromycin STELLA 500mg works 3. Before you use Clarithromycin STELLA 500mg 4. How to use Clarithromycin STELLA 500mg 5. Side effects 6. Storage and Disposal of Clarithromycin STELLA 500mg 7. Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT CLARITHROMYCIN STELLA 500MG IS USED FOR Clarithromycin STELLA 500mg is used to treat following infections: • Treatment of infections caused by pathogens sensitive to clarithromycin. • Infections of nose-pharynx tract (tonsillitis, pharyngitis) and of paranasal sinuses. • Infections of lower respiratory tract: bronchitis, bacterial pneumonia and atypical pneumonia. • Skin infections: impetigo, erysipelas, folliculitis, furunculosis and septic wounds. HOW CLARITHROMYCIN STELLA 500MG WORKS Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis. BEFORE YOU USE CLARITHROMYCIN STELLA 500MG Do not take Clarithromycin STELLA 500mg if you are taking any of the following medicines: Domperidone (used for nausea & vomiting). _When you must not use it _ • If you are allergic to clarithromycin, other macrolide antibiotics or any of the other ingredients of this medicine. • The following drugs must not be concomitant used with clarithromycin: • terfenadine, astemizole, cisapride and pimozide. • ergot alkaloids (ergotamine, dihydroergotamine) _._ Talk to your doctor if you are taking or have recently taken these above drugs. _Before you start use it _ Talk to your doctor or pharmacist before taking clarithromycin: • if you are in presence of severe renal impairment with or without coexisting hepatic impairment. • if you are using ranitidine bismuth citrate. • if you have history of acuteporphyria. • if you are pregnant Lire le document complet
DESCRIPTION Active ingredient: One tablet contains 500 mg of Clarithromycin. PHARMACODYNAMICS Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis. Additionally, the 14-hydroxyclarithromycin metabolite also has clinically significant antimicrobial activity. The 14-hydroxyclarithromycin is twice as active against Haemophilus influenzae microorganisms as the parent compound. However, for Mycobacterium avium complex (MAC) isolates the 14-hydroxymetabolite is 4 to 7 times less active than clarithromycin. The clinical significance of this activity against Mycobacterium avium complex is unknown. Clarithromycin is rapidly absorbed from the gastrointestinal tract, and undergoes first-pass metabolism; the bioavailability of the parent drug is about 55%. The extent of absorption is relatively unaffected by the presence of food. Peak concentrations of clarithromycin and its principal active metabolite, 14-hydroxyclarithromycin, are reported to be about 900 and 600 ng/ml, respectively after a single 250 mg dose by mouth; at steady state the same dose given every 12 hours as tablets produces peak concentrations of clarithromycin of about 1 mg/ml. The pharmacokinetics of clarithromycin are non-linear and dose dependent; high doses may produce disproportionate increases in peak concentrations of the parent drug, due to saturation of the metabolic pathways. Clarithromycin and its principal metabolite are widely distributed, and tissue concentrations exceed those in serum, in part because of intracellular uptake. Clarithromycin has been detected in breast milk. It is extensively metabolised in the liver, and excreted in faeces via the bile. At steady state about 20% and 30% of a 250 mg or 500 mg dose as tablets, respectively, is excreted in the urine as unchanged drug. 14-hydroxyclarithromycin as well as other metabolites are also excreted in the urine accounting for 10 to 15% of the dose. The terminal half-life of clarith Lire le document complet